Early Phase 1 Lupus Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 18 and 70 years old (male or female)
• Your blood counts, liver, kidneys, blood clotting, and lungs are all functioning at a minimum acceptable level (confirm with trial site for specific values)
• Your doctors expect you to live for more than 6 months
• If you have Inflammatory Muscle Disease (myositis): You have been diagnosed with a specific type of muscle inflammation (such as dermatomyositis, polymyositis, or a related condition) based on recognised medical guidelines, your disease is moderate to severe and has come back or stopped responding to treatment, and at least one specific disease-related antibody has been found in your blood
• If you have Inflammatory Muscle Disease: Previous treatments with steroids and at least one other immune-suppressing or biological medicine have not worked well enough, or you could not tolerate them
• If you have Immune Thrombocytopenia (ITP): You were diagnosed with ITP more than 3 months ago, your platelet count is very low on at least two separate tests, a specific antibody related to ITP has been found in your blood, and standard first-line treatments have not worked
• If you have Lupus (SLE): You were diagnosed with lupus at least 6 months ago using recognised medical guidelines, specific lupus-related antibodies are present in your blood, your disease activity score is high enough at screening, and at least one immune-suppressing or biological treatment has not worked or you could not tolerate it
• If you have Lupus with kidney involvement (Lupus Nephritis): A kidney biopsy within the last 12 months confirms a specific type of lupus nephritis, and urine protein levels are above a certain threshold (confirm with trial site)

Who may not be able to join:

• You have had a serious allergic reaction to any ingredient in the study drug
• You have a serious heart condition as defined by the trial (confirm with trial site for details)
• You have had a serious brain or nervous system condition or symptoms in the past 6 months
• You currently have cancer, or have had cancer in the past (some exceptions may apply — confirm with trial site)
• You have had significant bleeding problems (unrelated to ITP) or a blood clot in an artery or vein in the past 6 months
• You have tested positive for HIV, active Hepatitis B, Hepatitis C (with detectable virus), syphilis, or have active Epstein-Barr or cytomegalovirus infection above certain levels
• You have active tuberculosis, or latent (inactive) tuberculosis that has not been properly treated
• You have an ongoing viral, bacterial, or fungal infection that is not under control
• You have not completed the required "wash-out" period after stopping certain previous treatments (confirm with trial site for specific medicines and timeframes)
• If you have Inflammatory Muscle Disease: You have inclusion body myositis, a form with no visible muscle weakness (amyopathic), or myositis caused by another underlying condition; or you have severe muscle damage or uncontrolled complications outside the muscles
• If you have ITP: Your platelet count is extremely low (below 10×10⁹/L) and you are actively bleeding or have a bleeding severity score of 5 or above
• If you have Lupus: You have had a lupus crisis in the past 3 months, active lupus affecting your brain or nervous system, or severe complications such as serious anaemia or very low platelets caused by lupus
• The trial doctors have any other concern that participating may not be safe or appropriate for you

Important: Always verify eligibility with the trial site directly before applying.